A Phase 4 interventional study of Pharmacist based QI program and Usual Care in Chronic Kidney Disease, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-07-13.
Sponsored by University of Minnesota · Phase 4, Interventional, and Health services research
The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.
Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.
Research Plan:
The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry.
Methodology:
Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 2,199 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
Other: Pharmacist based QI program
Patients assigned to control will continue to receive care from their VA provider.
Other: Usual Care
Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
Patients in the control arm will continue to receive "usual care" from their VA providers.
Systolic Blood Pressure (SBP)
Average SBP for those with a baseline BP \> 130/80
Time frame: one year
Number of Participants With PTH Measurement During the Study Period
The primary process outcome was measurement of PTH during the study period.
Time frame: one year
| Milestone | Pharmacist Intervention | Control - Usual Care |
|---|---|---|
| Started | 1070 | 1129 |
| Completed | 518 | 1129 |
| Not completed | 552 | 0 |
Average SBP for those with a baseline BP \> 130/80
| mmHg | Pharmacist Intervention | Control - Usual Care |
|---|---|---|
| Systolic Blood Pressure (SBP) | 135.1 ± 17.4 | 134.4 ± 17.6 |
The primary process outcome was measurement of PTH during the study period.
| participants | Pharmacist Intervention | Control - Usual Care |
|---|---|---|
| Number of Participants With PTH Measurement During the Study Period | 502 | 182 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmacist Intervention | — | 0/1,070 (0%) | 0/1,070 (0%) |
| Control - Usual Care | — | 0/1,129 (0%) | 0/1,129 (0%) |
| Age, Continuous(years) | Pharmacist Intervention | Control - Usual Care | Total |
|---|---|---|---|
| Mean | 75.6 ± 8.2 | 75.7 ± 8.2 | 75.6 ± 8.2 |
| Sex: Female, Male(Participants) | Pharmacist Intervention | Control - Usual Care | Total |
|---|---|---|---|
| Female | 16 | 23 | 39 |
| Male | 1054 | 1106 | 2160 |
| Race/Ethnicity, Customized(participants) | Pharmacist Intervention | Control - Usual Care | Total |
|---|---|---|---|
| Black | 62 | 56 | 118 |
| Not Black | 1008 | 1073 | 2081 |
| Region of Enrollment(participants) | Pharmacist Intervention | Control - Usual Care | Total |
|---|---|---|---|
| United States | 1070 | 1129 | 2199 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Minnesota